Health products manufactured by Professional Botanicals Inc. may pose serious health risks

Starting date:
December 13, 2018
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Important Safety Information, Unauthorized products
Audience:
General Public
Identification number:
RA-68594

Issue

Health Canada is warning that all products manufactured by Professional Botanicals Inc. may pose serious health risks. The company is a contract manufacturer that also operates under the name Healthy Botanicals Inc.

Health Canada's assessment indicates that the company was manufacturing products under unsanitary conditions at a site that was not licensed by Health Canada at the time. During an inspection of the site (located at #16, 17075 Leslie Street, Newmarket, ON), Health Canada inspectors found that there was a lack of adequate quality control measures to ensure product quality and safety, and that no pest control measures were in place.

Health Canada has seized all of the products, prescription drug ingredients and manufacturing equipment found at the site, and suspended the 11 natural health product licences held by the company.

Products manufactured by this company may have been sold under various brand names, including Professional Botanicals Inc., either directly from the company or distributed to locations such as retail stores and weight loss clinics.

Health Canada's actions are further to the Department's follow-up regarding the sale of Vita-X Revitalizing Capsules, a natural health product manufactured by this company that was found to contain a prescription drug. As previously communicated, Health Canada has also suspended the licence for this product.

Unauthorized products have not been assessed by Health Canada for safety, quality or efficacy. It is illegal to sell unauthorized health products and conduct activities such as manufacturing, packaging and labelling of health products in Canada without the appropriate licensing and authorization from Health Canada. A site or establishment licence indicates that the company has met Health Canada's requirements for having processes and procedures in place to track and recall health products, and for manufacturing, packaging and labelling products in accordance with good manufacturing practices (a standard that helps to ensure the quality of health products sold to Canadians).

What you should do

  • Stop using these products. Consult your health care professional if you have used any of these products and have health concerns.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have a valid authorization for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
  • Report any health product-related adverse reactions or complaints to Health Canada.

Who is affected

  • Consumers who have bought or used the affected products.

Affected products

List of products for which Health Canada has suspended the licence (licenced products are indicated on the label by a Natural Product Number [NPN])

Product NPN Claim
Arterial Supreme 500 Ml 80029981 Help maintain and/or support cardiovascular health in adults
Chamomilla Supreme 80032208 Help relieve inflammatory conditions of gastrointestinal tract and mild digestive disturbances. Traditionally used as a calmative and/or sleep aid
Ginseng Herbal Medicine 80032258 Help support cognitive function and/or reduce mental fatigue. Help enhance physical capacity and performance (in case of physical stress)
Green Tea Extract 80033038 Source of antioxidants for the maintenance of good health. To be used with a program of reduced intake of dietary calories and increased physical activity (if possible) to help in weight management
Green Tea Extract 80033667 Source of antioxidants for the maintenance of good health
Limbada 80032373 Help support peripheral circulation
Liversol; Liver Supreme 80032200 Help support liver function
Magnesium & Potassium 80032472 A factor in the maintenance of good health
Mega Garlic 80033081 Help reduce elevated blood lipid levels and hyperlipidaemia and maintain cardiovascular health in adults
Opc Flow 80032564 Provides antioxidants for the maintenance of good health
V Tonic 80032468 Provides antioxidants for the maintenance of good health

List of unauthorized products that Health Canada seized from the site (see photos below):

Photo Product Size Claim (according to the label)
Bulk Supplements.com Longjack Extract (Tongkat Ali) Bulk Supplements.com Longjack Extract (Tongkat Ali) 100g No promoted use or claims on label
EU Pharma XXX-Lean EU Pharma XXX-Lean 120 capsules Weight loss
Herbal Lifestyle Herbal Lifestyle 20 capsules Weight loss
Nature's Clinic Happy Drops Nature's Clinic Happy Drops 100 mL No promoted use or claims on label
Neutrix Limbada Neutrix Limbada 10 capsules 100 capsules Workout aid, sexual enhancement
Neutrix Limbada Jack Neutrix Limbada Jack 2 capsules 20 capsules Sexual enhancement
Neutrix Red Rocket Neutrix Red Rocket 10 capsules Workout aid, sexual enhancement
Professional Botanicals Inc. Alpha Lipoic Acid Professional Botanicals Inc. Alpha Lipoic Acid 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Beta-Sitosterol Plus Professional Botanicals Inc. Beta-Sitosterol Plus 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Body Slim Professional Botanicals Inc. Body Slim 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Bovadrene Professional Botanicals Inc. Bovadrene 90 capsules No promoted use or claims on label
Professional Botanicals Inc. CandiaStat Professional Botanicals Inc. CandiaStat 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Children Dewormer Professional Botanicals Inc. Children Dewormer 500 mL No promoted use or claims on label
Professional Botanicals Inc. Co-Enzyme Q10 Professional Botanicals Inc. Co-Enzyme Q10 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Colostrum Professional Botanicals Inc. Colostrum 60 capsules No promoted use or claims on label
Professional Botanicals Inc. DHEA Professional Botanicals Inc. DHEA 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Diabetol Professional Botanicals Inc. Diabetol 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Digizyme Professional Botanicals Inc. Digizyme 90 capsules No promoted use or claims on label
Professional Botanicals Inc. EDTA Professional Botanicals Inc. EDTA 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Glucosamine Chondroitin and MSM Professional Botanicals Inc. Glucosamine Chondroitin and MSM 90 capsules No promoted use or claims on label
Professional Botanicals Inc. IB-Relieve Professional Botanicals Inc. IB-Relieve 90 capsules No promoted use or claims on label
Professional Botanicals Inc. L-Arginine Professional Botanicals Inc. L-Arginine 90 capsules No promoted use or claims on label
Professional Botanicals Inc. L-Carnitine Professional Botanicals Inc. L-Carnitine 90 capsules No promoted use or claims on label
Professional Botanicals Inc. L-Glutamine Professional Botanicals Inc. L-Glutamine 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Limbada Fertility Professional Botanicals Inc. Limbada Fertility 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Lipid Formula 1 Professional Botanicals Inc. Lipid Formula 1 90 capsules No promoted use or claims on label
Professional Botanicals Inc. MSM Cream Professional Botanicals Inc. MSM Cream 30 mL Joint pain relief
Professional Botanicals Inc. Nattokinase Plus Professional Botanicals Inc. Nattokinase Plus 90 capsules Reduce blood pressure, prevent blood clots, promote vascular health
Professional Botanicals Inc. Oral Chelate Professional Botanicals Inc. Oral Chelate 90 capsules Heavy metal removal, chelating agent
Professional Botanicals Inc. Paragona Professional Botanicals Inc. Paragona 90 capsules Targets parasites of the gastrointestinal tract
Professional Botanicals Inc. Phytotheanine Professional Botanicals Inc. Phytotheanine 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Probiotics Professional Botanicals Inc. Probiotics 90 capsules Relieve symptoms of allergy, cold, flu or arthritis, regulate digestion and fat metabolism
Professional Botanicals Inc. Prostasol Professional Botanicals Inc. Prostasol 90 capsules Reduce bloating and water retention, improve sleep, promote urinary tract and prostate health
Professional Botanicals Inc. Rheumaplex Professional Botanicals Inc. Rheumaplex 90 capsules Helps reduce pain, stiffness, inflammation and swelling in joints due to arthritis
Professional Botanicals Inc. Thyrone Professional Botanicals Inc. Thyrone 90 capsules No promoted use or claims on label
Professional Botanicals Inc. Varicon Plus Professional Botanicals Inc. Varicon Plus 90 capsules No promoted use or claims on label

 

Media enquiries

Health Canada
613-957-2983
hc.media.sc@canada.ca

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

At Health Canada's request, the company has agreed to stop manufacturing and selling, and to recall, all health products manufactured at its facility.

Should additional safety concerns be identified related to this issue, Health Canada will take appropriate action and inform Canadians as necessary.

Images

Select thumbnail to enlarge - opens in a new window